An Educational Video to Improve Patient Comprehension of Midurethral Sling

The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.

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Key information

Conditions

Stress Urinary Incontinence Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Knowledge, Attitudes, Practice Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Irvine

Orange, California, 92628, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital

Exclusion criteria

< 18 years of age
Non-English speaking or requiring interpreter assistance
Presence of cognitive dysfunction
Women receiving a repeat midurethral sling (not primary)
Women with a history of pelvic mesh complication (erosion, pain, history of mesh excision)
Pregnant women

Treatment and study plan

Educational Video

Other

Short educational video describing the mid-urethral sling procedure

Educational leaflet

Other

Standard educational leaflet describing the mid-urethral sling procedure

Primary outcomes

Patient knowledge questionnaire (investigator-created)

Time frame: 6 weeks

The change in participant knowledge as measured with a patient knowledge questionnaire. This questionnaire was created by the study investigators and piloted by physicians within our institutions. It was submitted to and approved by our IRB for use in this study. This is a 15-point questionnaire (true/false/unknown answer choices) in which 1 point is given for each correct response and 0 points given for incorrect or unanswered questions (minimum score: 0/15, maximum score: 15/15). The questions pertain to the risks, benefits, and procedure of the mid-urethral sling surgery. Higher scores indicate better participant knowledge. A subscale of mesh-related questions will also be examined. This subscale reports the participant knowledge pertaining to complications and procedural knowledge specific to the use of mesh in the mid-urethral sling. The scale of this subset ranges from 0/5 to 5/5, with higher scores indicating greater participant knowledge.

Sponsors and collaborators

Lead sponsor

Felicia Lane

Other

Collaborators

Kaiser Permanente

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2021
First posted: Jan 18, 2019
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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